Rectal CancerNCT07260526
Response-adapted Total Neoadjuvant Therapy Guided by Induction Chemotherapy in Early- and Intermediate-risk Low Rectal Cancer for Implementation of a Watch-and-wait Strategy
An observational study of Rectal Cancer, run by West China Hospital at 1 site in China.
Trial summary
This study investigates the feasibility of an organ-preserving "watch-and-wait" strategy in patients with mid-to-low rectal cancer who achieve a good response after total neoadjuvant therapy (TNT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mid-to-low rectal cancer who respond well to induction chemotherapy and subsequently complete total neoadjuvant therapy in order to observe the organ preservation rate after total neoadjuvant therapy.
Who may be able to join
- Age: 18-80 years; no restriction on sex.
- Histologically confirmed rectal adenocarcinoma with immunohistochemistry and/or genetic testing showing pMMR/MSS status.
- Tumor characteristics assessed by chest-abdominal CT, rectal ultrasound, and MRI meeting all of the following criteria:
- The lower edge of the tumor is ≤5 cm from the anal verge as measured by digital rectal examination or MRI;
- Clinical stage cT1-3abN0-1M0 (for cT1N0, patients suitable for endoscopic resection are excluded);
- MRF (-) (>1 mm), EMVI (±);
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- Negative lateral lymph nodes and <7 mm in size;
- Maximum tumor length ≤5 cm;
- Tumor circumference involvement ≤2/3.
- After receiving at least two cycles of induction chemotherapy with the XELOX regimen, MRI assessment shows treatment response (tumor length reduced by ≥30% compared with baseline).
- Completion of total neoadjuvant therapy (TNT), including long-course chemoradiotherapy and consolidation chemotherapy (radiotherapy: 25-28 fractions; chemotherapy: 6-8 cycles).
- (For the prospective cohort) Provision of written informed consent for participation in this observational study.
Who cannot join
- Patients with a history of, or concurrent, other malignant tumors (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
- Patients with severely incomplete clinical data that preclude effective evaluation;
- (For the prospective cohort) Patients who refuse to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China hospital, Sichuan University
Chengdu, Sichuan, 610041
Ziqiang Wang, M.D., +86 189 8060 2028, wangziqiang@scu.edu.cn
About this study
This study investigates the feasibility of an organ-preserving "watch-and-wait" strategy in patients with mid-to-low rectal cancer who achieve a good response after total neoadjuvant therapy (TNT). By retrospectively and prospectively analyzing patients who complete TNT following effective induction chemotherapy, the study aims to assess organ preservation rates and evaluate whether non-surgical management can provide comparable oncologic outcomes to radical surgery while improving functional recovery and quality of life.
Read the detailed description
With the evolution of rectal cancer treatment concepts, achieving optimal oncologic outcomes while preserving organ function and improving patients' quality of life has become a major goal in the management of low rectal cancer. Multiple studies have reported that for patients who achieve a clinical complete response (cCR) after total neoadjuvant therapy (TNT), a watch-and-wait (organ preservation) strategy-with close follow-up and salvage surgery when necessary-yields 5-year disease-free survival (DFS) and overall survival (OS) rates comparable to those of patients who undergo radical surgery and achieve a pathological complete response (pCR). Moreover, compared with total mesorectal excision (TME), patients managed with a watch-and-wait approach demonstrate significantly better physical, cognitive, role, and social-emotional functioning, along with lower incidences of bowel, sexual, and urinary dysfunction.
This study aims to retrospectively and prospectively include patients with mid-to-low rectal cancer who respond well to induction chemotherapy and subsequently complete TNT, in order to observe the organ preservation rate after TNT and to preliminarily evaluate the feasibility of this treatment approach within a watch-and-wait strategy.
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, total neoadjuvant therapy, watch-and-wait strategy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ITNT group | Patients who achieve a good response after total neoadjuvant therapy and receive organ preservation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year organ preservation rate
defined as the proportion of the following two groups among the total study population：① Patients evaluated as having a clinical complete response (cCR) or near cCR at 8 weeks after radiotherapy who choose a watch-and-wait strategy and maintain cCR for 1 year; ② Patients evaluated as having a cCR or near cCR at 8 weeks after radiotherapy who ultimately undergo local excision and remain recurrence-free for 1 year without requiring salvage surgery.
Measured: 1 year after completion of neoadjuvant radiotherapy
Secondary outcomes (2)
1-year metastasis-free survival
time from the start of neoadjuvant chemotherapy to the occurrence of distant metastasis
Measured: 1 year after total neoadjuvant therapy
1-year overall survival
time from the start of neoadjuvant chemotherapy to death from any cause.
Measured: 1 year after total neoadjuvant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziqiang Wang,MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260526
- Sponsor's protocol ID
- WCH20250924
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers are encouraged to apply for the full study protocol, study data, and analytic code upon reasonable request by contacting the primary investigator (Ziqiang Wang).
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response-adapted Total Neoadjuvant Therapy Guided by Induction Chemotherapy in Early- and Intermediate-risk Low Rectal Cancer for Implementation of a Watch-and-wait Strategy
- ClinicalTrials.gov ID
- NCT07260526
- Acronym / sponsor ID
- WCH20250924
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, total neoadjuvant therapy, watch-and-wait strategy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the feasibility of an organ-preserving "watch-and-wait" strategy in patients with mid-to-low rectal cancer who achieve a good response after total neoadjuvant therapy (TNT). By retrospectively and prospectively analyzing patients who complete TNT following effective induction chemotherapy, the study aims to assess organ preservation rates and evaluate whether non-surgical management can provide comparable oncologic outcomes to radical surgery while improving functional recovery and quality of life.
Detailed description
With the evolution of rectal cancer treatment concepts, achieving optimal oncologic outcomes while preserving organ function and improving patients' quality of life has become a major goal in the management of low rectal cancer. Multiple studies have reported that for patients who achieve a clinical complete response (cCR) after total neoadjuvant therapy (TNT), a watch-and-wait (organ preservation) strategy-with close follow-up and salvage surgery when necessary-yields 5-year disease-free survival (DFS) and overall survival (OS) rates comparable to those of patients who undergo radical surgery and achieve a pathological complete response (pCR). Moreover, compared with total mesorectal excision (TME), patients managed with a watch-and-wait approach demonstrate significantly better physical, cognitive, role, and social-emotional functioning, along with lower incidences of bowel, sexual, and urinary dysfunction.
This study aims to retrospectively and prospectively include patients with mid-to-low rectal cancer who respond well to induction chemotherapy and subsequently complete TNT, in order to observe the organ preservation rate after TNT and to preliminarily evaluate the feasibility of this treatment approach within a watch-and-wait strategy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ITNT group | – | –Patients who achieve a good response after total neoadjuvant therapy and receive organ preservation strategy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mid-to-low rectal cancer who respond well to induction chemotherapy and subsequently complete total neoadjuvant therapy in order to observe the organ preservation rate after total neoadjuvant therapy.
Key inclusion criteria (12 listed)
- Age: 18-80 years; no restriction on sex.
- Histologically confirmed rectal adenocarcinoma with immunohistochemistry and/or genetic testing showing pMMR/MSS status.
- Tumor characteristics assessed by chest-abdominal CT, rectal ultrasound, and MRI meeting all of the following criteria:
- After receiving at least two cycles of induction chemotherapy with the XELOX regimen, MRI assessment shows treatment response (tumor length reduced by ≥30% compared with baseline).
- Completion of total neoadjuvant therapy (TNT), including long-course chemoradiotherapy and consolidation chemotherapy (radiotherapy: 25-28 fractions; chemotherapy: 6-8 cycles).
Key exclusion criteria (3 listed)
- Patients with a history of, or concurrent, other malignant tumors (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
- Patients with severely incomplete clinical data that preclude effective evaluation;
- (For the prospective cohort) Patients who refuse to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1-year organ preservation rate
Time frame: 1 year after completion of neoadjuvant radiotherapy
defined as the proportion of the following two groups among the total study population：① Patients evaluated as having a clinical complete response (cCR) or near cCR at 8 weeks after radiotherapy who choose a watch-and-wait strategy and maintain cCR for 1 year; ② Patients evaluated as having a cCR or near cCR at 8 weeks after radiotherapy who ultimately undergo local excision and remain recurrence-free for 1 year without requiring salvage surgery.
2 secondary outcomes
1-year metastasis-free survival
Time frame: 1 year after total neoadjuvant therapy
1-year overall survival
Time frame: 1 year after total neoadjuvant therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Yes. Researchers are encouraged to apply for the full study protocol, study data, and analytic code upon reasonable request by contacting the primary investigator (Ziqiang Wang).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ziqiang Wang, M.D. (+86 18980602028, wangziqiang@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year organ preservation rate (time frame: 1 year after completion of neoadjuvant radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.